While early notification to the FDA would help the agency better prepare for a potential drug shortage, such reporting is only one piece of an effective solution — it is reactive, not proactive. Currently, there is no single entity that keeps tabs on all potential contributors to a drug shortage. What the system needs is a clearinghouse of information that draw on what manufacturers know about pending production problems, what suppliers of the raw materials know about the availability of their ingredients and what the FDA is privy to regarding which companies are applying for approval for new drugs.
To that end, the Generic Pharmaceutical Association (GPhA) has submitted a proposal to the Department of Health and Human Services for an Accelerated Recovery Initiative, which would involve the entire drug manufacturing and supply chain. Its key feature: an independent third party that would serve as the liaison between generic drug makers and the FDA to coordinate and ensure an adequate supply of drugs. “The third party would collate information on inventories and inspections and drug supplies, and absorb it and regurgitate it back to the appropriate people,” says David Gaugh, senior vice president for regulatory sciences at GPhA.
Adds Ralph Neas, GPhA’s president and CEO: “If we have five or six manufacturers making a sterile injectable production, and say A and B are having problems. Then the third party would see what C, D and E could do to work out production issues.”
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By looping in the FDA, the independent party would also know if there is another company waiting for approval of the same drug that the agency could expedite.
Whether these measures will be enough and whether they will actually be implemented are two different issues. But for patients like Robinson, whatever the solution, it may be too late. Although her hospital now has enough Doxil to treat its patients, she can no longer take the drug for safety reasons. By taking the alternative drugs, she reached her lifetime limit of that class of medication. “I don’t have any confidence that the shortages are gone,” she says. “I expect it’s going to happen again, just because of the way it happened — there wasn’t any concern for patients. I felt like there was lots of concerns for the producers of medicines and for regulations, but there didn’t seem to be any concern at all for the patient.”